In a recent press release, Cerapedics, a private ortho-biologics company, announced that results from a clinical trial evaluating i-FACTOR Peptide Enhanced Bone Graft in non-instrumented lumbar fusion surgery has been published in the May 2020, Volume 20, Issue 5 print of The Spine Journal as the lead article.
The data demonstrate that elderly patients in Denmark treated with i-FACTOR bone graft plus local bone had a statistically significantly higher fusion rate compared to allograft plus local bone.
“In Scandinavia, surgeons often consider performing non-instrumented fusion when there is instability in elderly patients, but allograft bone has notoriously low fusion rates in this population,” said Dr. Michael Kjær Jacobsen, principal investigator. “i-FACTOR shows an increased fusion rate versus allograft.”
Dr. Michael Kjær Jacobsen, at the Center for Spine Surgery and Research in Southern Denmark, led the double-blind, prospective, randomized study in more than 100 patients (60 years or older). Participants suffered from degenerative spondylolisthesis and underwent decompression and non-instrumented posterolateral fusion surgery, randomized to either i-FACTOR bone graft or fresh frozen allograft bone, both mixed with local bone graft. Results showed the fusion rate was significantly higher in the i-FACTOR bone graft group (50 percent) compared to the allograft group (20 percent) at one year (p <0.001). Patient reported outcomes at baseline and follow-up were similar between the two groups. Longer term follow-up to evaluate the maintenance of clinical outcomes is in process.